Angina Pectoris, Microvascular Angina, Myocardial Bridge of Coronary Artery, Vasospastic Angina
Conditions
Brief summary
The goal of this clinical trial is to learn if targeted medical therapy will improve symptoms and quality of life in patients with angina and non-obstructive coronary arteries compared to placebo, after the underlying cause of the chest pain has been ascertained by coronary function testing. Participants will be treated with either medications that target the underlying cause of their chest pain or placebo for 4 weeks after a drug titration phase of 1-3 weeks. They will be asked to complete a series of questionnaires to evaluate their quality of life at the beginning and end of the study.
Interventions
DRUGAmlodipine
Amlodipine taken once orally daily at a starting dose of 2.5mg, uptitrated to a maximum of 10mg if tolerated.
DRUGNebivolol
Nebivolol taken once orally daily at a starting dose of 5mg, uptitrated to a maximum of 20mg if tolerated.
DRUGPlacebo
Placebo taken once orally daily.
Sponsors
American Heart Association
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients with stable angina referred to the Stanford University Hospital cardiac catheterization laboratory for clinically indicated coronary function testing are eligible for inclusion into the study. Specific inclusion criteria for randomization: * Absence of significant epicardial coronary artery disease on angiography * Fractional flow reserve \> 0.80 And ≥ 1 of the following: * Epicardial coronary spasm on acetylcholine testing * Microvascular spasm on acetylcholine testing * Coronary flow reserve \< 2.5 * Index of microcirculatory resistance ≥ 25 * Myocardial bridge on intravascular ultrasound with dobutamine resting full-cycle ratio ≤ 0.76
Exclusion criteria
* Acute coronary syndrome less than one week prior to enrolment * Cardiomyopathy * Contraindications to beta-blockers or calcium channel blockers * Baseline systolic blood pressure \< 95 mmHg * Baseline heart rate \< 55 bpm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seattle Angina Questionnaire summary score | 5-7 weeks (depending on drug titration period) | Change in Seattle Angina Questionnaire summary score at follow-up compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Satisfaction Questionnaire for Medication score | 5-7 weeks (depending on drug titration period) | Change in Treatment Satisfaction Questionnaire for Medication score at follow-up compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome. |
| EuroQol 5 dimension - 5L index score | 5-7 weeks (depending on drug titration period) | Change in EuroQol 5 dimension score - 5L index score at follow-up compared to baseline. The index ranges from -0.573 to 1.000, with a higher score indicating a better outcome. |
| EuroQol 5 dimension - 5L visual analogue score | 5-7 weeks (depending on drug titration period) | Change in EuroQol 5 dimension score - 5L visual analogue score at follow-up compared to baseline. The index ranges from 0 - 100, with a higher score indicating a better outcome. |
| Seattle Angina Questionnaire summary score stratified by specific chest pain endotypes | 5-7 weeks (depending on drug titration period) | Change in Seattle Angina Questionnaire summary score stratified by specific chest pain endotypes at follow-up compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome. |
| EuroQol 5 dimension - 5L index score stratified by specific chest pain endotypes | 5-7 weeks (depending on drug titration period) | EuroQol 5 dimension - 5L index score stratified by specific chest pain endotypes at follow-up compared to baseline. The index ranges from -0.573 to 1.000, with a higher score indicating a better outcome. |
| EuroQol 5 dimensions - 5L visual analogue score stratified by specific chest pain endotypes | 5-7 weeks (depending on drug titration period) | EuroQol 5 dimensions - 5L visual analogue score stratified by specific chest pain endotypes at follow-up compared to baseline. The index ranges from 0 - 100, with a higher score indicating a better outcome. |
| PHQ-4 score | 5-7 weeks (depending on drug titration period) | Change in PHQ-4 at follow-up compared to baseline. The score ranges from 0 - 12, with a higher score indicating a worse outcome. |
| Treatment Satisfaction Questionnaire for Medication score stratified by specific chest pain endotypes | 5-7 weeks (depending on drug titration period) | Treatment Satisfaction Questionnaire for Medication scores stratified by specific chest pain endotypes at follow-up compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome. |
| Seattle Angina Questionnaire summary score stratified by baseline angina frequency | 5-7 weeks (depending on drug titration period) | Change in Seattle Angina Questionnaire summary score stratified by baseline angina frequency at at follow-up compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome. |
| Proportion of patients with good response, no angina, and excellent health status | 5-7 weeks (depending on drug titration period) | Difference between targeted medical therapy group and placebo group in proportion of patients with good response (Seattle Angina Questionnaire summary score ≥ 10), no angina (Seattle Angina Questionnaire angina frequency score = 100), and excellent health status (Seattle Angina Questionnaire summary score ≥ 75). |
| Safety endpoints | Baseline | Incidence of bleeding, coronary dissection, stroke, periprocedural myocardial infarction, non-self-limiting arrhythmias during the index coronary function testing procedure |
| Major adverse cardiac events | 5-7 weeks (depending on drug titration period) | Difference between targeted medical therapy group and placebo group in incidence of cardiac death, myocardial infarction, and hospital presentation for unstable angina. |
| PHQ-4 scores stratified by specific chest pain endotypes | 5-7 weeks (depending on drug titration period) | PHQ-4 score stratified by specific chest pain endotypes at follow-up compared to baseline. The score ranges from 0 - 12, with a higher score indicating a worse outcome. |
Countries
United States
Contacts
Primary ContactChristopher Wong, MBBS, PhD
Outcome results
None listed